Proactive familial breast cancer risk assessment in primary care (Phase 2)

ISRCTN	ISRCTN16117197
DOI	https://doi.org/10.1186/ISRCTN16117197
Protocol serial number	15872
Sponsor	University of Nottingham (UK)
Funder	NIHR (UK) - School for Primary Care Research; Grant Codes: Project 206

Submission date: 20/12/2013
Registration date: 20/12/2013
Last edited: 21/09/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-at-identifying-women-at-increased-risk-breast-cancer-due-to-family-history

Contact information

Miss Christina Brindley
Scientific

Division of Primary Care
13th Floor Tower Building
University Park
University of Nottingham
Nottingham
NG7 2RD
United Kingdom

Email	christina.brindley@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised interventional; Design type: Prevention, Process of Care, Screening
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Proactive familial breast cancer risk assessment in primary care: feasibility of an optimised intervention to improve identification and care of women at risk (Phase 2)
Study objectives	Some women with relatives previously diagnosed with breast cancer may be at higher than average risk of developing breast cancer. It is important to identify these women so they can benefit from specialist services for early diagnosis and better life expectancy. National guidelines on how to identify women at familial risk of breast cancer were issued in 2004. However, some women with a high risk, particularly younger women and those from less educated and minority backgrounds, are not being identified. In contrast, other women at average risk are inappropriately referred to specialist services. This study aims to develop a more systematic approach to identify women's familial risk of breast cancer. The intervention will involve women completing a family history questionnaire already tested for effectiveness combined with practices using decision-making software to calculate breast cancer risk and to better target referral to specialist services. We will compare what happens now (usual care) with a proactive way of identifying women, aged 30-60, with familial breast cancer risk. This study will: 1. Develop and refine the intervention in women aged 30-60 in primary care 2. Use a combination of different research methods to begin to understand the benefits to the NHS of using the intervention.
Ethics approval(s)	Nottingham 2, First MREC approval date 27/01/2014, ref: 14/EM/009
Health condition(s) or problem(s) studied	Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention	General practices are randomised to either the intervention arm (proactively identifying women aged 30-60 and using the decision-support software) or the control arm. 16 women recruited for focus groups 1 and 2 (8 per focus group) Approximately 35 women from 6 control practices opportunistically identified. Approximately 350 women from 6 intervention practices = 2100 (however this may be more or less depending onpractice list size). The interviews following the exploratory trial will involve women already recruited to the study and included in the numbers above. 6-12 GPs for interviews from the intervention group. 6-8 administrative staff for interviews. Family History Questionnaire, This will be used with decision-making software Follow Up Length: 8 month(s) Study Entry : Registration and One or More Randomisations
Intervention type	Other
Primary outcome measure(s)	Proactively identify women at risk of familial breast cancer; Timepoint(s): Final analysis
Key secondary outcome measure(s)	1. Optimise study design for a further trial; Timepoint(s): Final analysis will identify whether this study is successful in meeting its aims 2. Streamlined referrals to specialist services; Timepoint(s): Measured through participant medical records at 6 month follow-up
Completion date	30/06/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	2163
Key inclusion criteria	Eligibility for General Practice anonymised MIQUEST searches: General Practices in Nottinghamshire who consent to undertake anonymised database searches. Eligibility for Focus Group 1: Women with a family history of breast cancer and no previous referral to specialist services, identified through newspaper adverts in Nottingham newspapers. Participants will be aged between 18 to 70 years. Eligibility for Focus Group 2: Women identified with a family history of breast cancer with previous experience of specialist services identified through the Royal Derby Hospital. Participants will be aged between 18 to 70 years. Eligibility criteria for patient participants for the exploratory trial and nested qualitative study: 1. Women aged between 30 and 60 years 2. Registered with a participating GP practice 3. Able to complete the family history questionnaire in English (assistance from a household member is permitted) 4. Have NO history of breast or ovarian cancer 5. Must NOT have undergone a Familial Breast Cancer Assessment at specialist services in the previous 12 months 6. Must not have participated in the focus groups Eligible health professionals for the exploratory trial are: Consenting GPs (principals, salaried, registrars), nurses (including nurse practitioners/practice nurses) and administration staff at the study general practices in Derbyshire. Eligible health professionals for the nested qualitative study are: 1. Consenting GPs (principals, salaried, registrars), nurses (including nurse practitioners/practice nurses) and administration staff at the study general practices in Derbyshire. 2. Nominated lead GPs involved in providing the information or risk communication/consultation with patients from each intervention practice 3. Designated administrative staff entering the FHQ data into FaHRAS (risk assessment software); Target Gender: Male & Female; Upper Age Limit 70 no age limit or unit specified ; Lower Age Limit 18 no age limit or unit specified
Key exclusion criteria	Exclusion criteria for General Practice undertaking the anonymised MIQUEST searches: General Practices who do not consent to undertake anonymised database searches. Exclusion criteria for Focus Group 1: Women who do not have a family history of breast cancer Women who were referred to specialist services as part of their NHS care for breast cancer/suspected breast cancer. Exclusion criteria for Focus Group 2: Women who do not have a family history of breast cancer Women who were not referred to specialist services, for familial breast cancer risk, at Royal Derby Hospital. Exclusion criteria for patient participants for the exploratory trial and nested qualitative study: 1. Women outside the age range of 30-60 years 2. Not registered with a participating practice 3. Unable to provide written informed consent 4. Unable to complete the family history questionnaire in English 5. History of breast or ovarian cancer Exclusion criteria for Focus Group 2: Women who do not have a family history of breast cancer Women who were not referred to specialist services, for familial breast cancer risk, at Royal Derby Hospital. Exclusion criteria for patient participants for the exploratory trial and nested qualitative study: 1. Women outside the age range of 30-60 years 2. Not registered with a participating practice 3. Unable to provide written informed consent 4. Unable to complete the family history questionnaire in English 5. History of breast or ovarian cancer 6. Undergone a Familial Breast Cancer Assessment at specialist services in previous 12 months 7. Must not have participated in the focus groups. 8. Patients considered by the General Practitioners to be inappropriate to recruit due to psychosocial reasons. Exclusion criteria for health professionals for the exploratory trial and nested qualitative study are: GPs (principals, salaried, registrars), nurses (including nurse practitioners/practice nurses) and administration staff at general practices not participating in the study.
Date of first enrolment	10/02/2014
Date of final enrolment	30/08/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Nottingham

Nottingham
NG7 2RD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to consent not being obtained from participants for datasets to be shared. The study was set up in 2014 and sharing of datasets was not included in the ethics and R&D applications.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results		21/09/2021	21/09/2021	No	Yes

Editorial Notes

21/09/2021: Link to plain English results added.
14/12/2018: IPD sharing statement added.
12/12/2018: The intention to publish date was changed from 30/06/2018 to 31/03/2019.
19/10/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/08/2015 to 30/06/2016.
2. Publication and dissemination plan and IPD sharing statement added.